Targeted Immunotherapy for High-Risk T-Cell ALL & Lymphoma After Transplant
This study is testing the safety of a targeted immunotherapy called daratumumab (DARA) given after a stem cell transplant (allogeneic hematopoietic stem cell transplantation, or AlloHCT) for children, adolescents, and young adults (up to 39 years old) with high-risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). You may be eligible if your T-cell ALL is in a second or later remission, or if your T-LLy has responded completely to re-induction therapy. The main goal is to see if daratumumab is safe, specifically looking at any dose-limiting toxicities within 60 days. This study is currently unclear on its recruitment status and plans to enroll 30 participants.
- Study design
- This is a Phase 1 interventional study designed to determine the safety of daratumumab. It will enroll 30 participants, with the first 15 patients testing three different dose levels.
- What's involved
- Participants will receive daratumumab intravenously weekly for 8 weeks, then every two weeks for 16 weeks, and finally every four weeks until day +270 after transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety endpoint is measured at 60 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
At a glance
Conditions
NCT04972942
Where you'd take part
This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Children's Hospital Colordao
Aurora, Coloradostudy coordinator listed
Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Children's National Medical Center
Washington D.C., District of Columbiastudy coordinator listed
Not yet recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michiganstudy coordinator listed
Recruiting
Loma Linda University Children's Hospital
Loma Linda, Californiastudy coordinator listed
Recruiting
New York Medical College
Vallhala, New Yorkstudy coordinator listed
Recruiting
Riley Children's Hospital
Indianapolis, Indianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Mitchell Cairo, MD · STUDY_CHAIR · New York Medical College
- Troy Quigg, DO · STUDY_CHAIR · Helen DeVos Children's Hospital
- Allyson Flower, MD · STUDY_CHAIR · New York Medical College
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Patients with dose limiting toxicity (per CTCAE v.5)60 days
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab